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Ketamine and Hydromorphone for Patient Controlled Pain Relief in Children's Mucositis

NCT00474110 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2010-11-01

No results posted yet for this study

Summary

The treatment of cancer in children may result in an extremely painful condition called oral mucositis when the cells lining the mouth are injured due to the cancer medication. Patients with this condition are often unable to take anything by mouth or to swallow their own saliva. This severe pain may last for as long as 2 weeks. A survey of our previous 22 patients showed high daily pain scores despite the use of intravenous (given through a small tube in a vein) opioid medications (family of pain relieving drugs, e.g. morphine and hydromorphone).

The purpose of this pilot study is to determine which of 3 concentrations of ketamine to combine with hydromorphone to provide the best pain relief with minimum side effects. The results from this study will allow us to do a larger study to compare the best concentration found from this study to standard treatment. If successful, this combination of ketamine and hydromorphone will also be used to treat other pain problems in children.

Conditions

Interventions

DRUG

Ketamine & hydromorphone

See Detailed Description

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Carolyne Montgomery, MD · University of British Columbia

  • Mark Ansermino, MD · University of British Columbia

  • Caron Strahlendorf, MD · University of British Columbia

  • Robert Purdy, MD · University of British Columbia

  • Colleen Court, MD · University of British Columbia

  • Joanne Lim · University of British Columbia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00474110 on ClinicalTrials.gov